HGRAC Affairs Manager

2 weeks ago

Shanghai, Shanghai, China Amgen Full time

Purpose / Accountabilities


•HGRAC Compliance Oversight capability set up and monitoring system functions


•SOP, Training and Process update for new implementation rules, regulations and management system updates


•Collaborate with LST/CST on HGRAC application submissions, including consultation about the regulation requirements and logistic review.


•Internal and External partnership build up

Responsibilities


•HGRAC Compliance Oversight capability set up and monitoring system functions:

  • Implement internal HGRAC compliance oversight and activities per established Amgen standards and operations. Oversee appropriate distribution of HRGAC activities/ tasks to ensure operational effectiveness.
  • Provide oversight on HGRAC submissions across China study portfolio, lead timely communication of status and issues effectively.
  • Provide input for HGRAC related Inspection& requested self-check reporting.
  • Develop CAPAs to address any performance and compliance gaps identified, in collaboration with QCA function


•​SOP, Training and process update for new implementation rules, regulations and management system updates:

  • Develop and maintain Amgen HGRAC SOPs/Work Instructions working closely with Amgen QCA (Quality, Compliance & Audit) team and identified BPOs.
  • Develop and deliver training on an ongoing basis to key stakeholders involved in the HGRAC process.
  • Lead/project manage and /or participate to provide input on relevant Amgen tasks force teams related to HGRAC activities, as assigned by line manager.
  • Lead Internal Processes optimization: User friendly application form optimization, Application review & approval process optimization, Quality check list for application review, Site filing process efficiency improvement, eTMF filing process optimization, etc.. Lead structured working team set up and working together on process improvement.
  • Develop standard wording & templated from HGRAC perspective for study related documents: Contract, Intellectual property, Protocol China CSS etc.
  • HGRAC management SharePoint site re-org: location for effective application documents etc.

​


•Internal and External partnership build up:

  • Serve as Amgen China SME for all HGRAC-related activities, working with local and global cross-functional stakeholders and respective study team leads to ensure the HGRAC applications are conducted in a timely and compliant manner.
  • Connection with external industry patterners to better navigate HRGAC submissions. Work with Head of HGRAC Affairs to collect industry intelligence and gain industry insight.
  • Maintain and support communication with regulatory or relevant regulatory agency to ensure Amgen processes compliant with regulations and standards.
  • Participate on appropriate professional and continuing education trainings externally available and internally organized at Covance to continuously build knowledge and expertise on HGRAC-related requirements.
  • Collaborate with LST/CST on HGRAC application submissions:
  • Perform Amgen internal logistic review of HGRAC applications prior to submission.


•Other responsibilities:

  • Work as key team member to create and maintain the Amgen bi-lingual application Form templates.
  • Provide HGRAC Affairs Mailbox management and triage the queries received in the Mailbox.
  • Conduct on-site visit with HGRAC window officers in Beijing as really needed due to business-critical reason.

​

Qualifications

Preferred Qualifications

  • MSc/BA/BS/BSc in life science or relevant
  • Minimum 5 years ofexperience within Pharmaceutical/CRO industry, withprior clinical operations experience; HGRAC submissions experience preferred
  • Quality control or quality system set up experience
  • Good written and oral communication skills in both English and Mandarin

Knowledge (China-Specific)

  • HGR Regulations, associated guidelines
  • Basic knowledge of clinical trial management including clinical trial processes
  • Understanding of ICH/GCP guidelines.

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